FDA

PHAI Takes Action Against Puff Bar for Violating Massachusetts’ Ban on Flavored e-Cigarettes

CONTACTS: Mark Gottlieb                                                             Meredith Lever(617) 216-0779                                                            (617) 373-8066mark@phaionline.org                                          meredith@phaionline.org  FOR IMMEDIATE RELEASE  Puff Bar Charged With Violating Massachusetts’ Ban on Flavored e-CigarettesIn direct violation of state law, Puff Bar sells flavored, disposable e-cigarettes that appeal to teens  BOSTON, MA (June 11, 2020) – Today, the Public Health Advocacy Institute (PHAI) at Northeastern University School of Law

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FDA Reboots Tobacco Regulation with Harm Reduction

On Friday, July 28, 2017, U.S. Food and Drug Administration (“FDA”) Commissioner Scott Gottlieb unveiled a revamped approach to tobacco product regulation in an announcement that surprised tobacco companies, investors, and the public health community in equal measure.  The goal, as articulated by Gottlieb, will be to regulate products so as to encourage migrating existing consumers from

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PHAI’s Gottlieb Comments on FDA Regulations’ Effect on Vaping Industry on All Things Considered

On August 8, 2016, new regulations by the FDA went into effect that have a profound impact on a major segment of the electronic cigarette industry:  vape shops.  The shops that mix flavors for vaping products are now considered to be manufacturers and subject to the same requirements as manufactures owned by the companies that

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PHAI Submits Comments to FDA on Deeming Rule Focusing on E-Cigarettes

Today the Public Health Advocacy Institute submitted comments  to the U.S. Food and Drug Administration on its proposed rule to include cigars, little cigars, electronic cigarette products, and tobacco for hookah smoking among the products for which it can legally issues rules and regulations.  This is known as a “deeming rule.”  The deeming rule is a

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PHAI’s Gottlieb Calls Out FDA and White House for Failing to Aggressively Implement the Family Smoking Prevention and Tobacco Control Act

In an editorial published in the May, 2014 issue of the journal, Tobacco Control, PHAI’s Executive Director, Mark Gottlieb, calls the FDA’s approach to implementation of the Family Smoking Prevention and Tobacco Control Act, “Overcautious,” and urges the agency and the White House to take a much more aggressive approach to saving lives. The summary

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PHAI urges FDA to prohibit the sale and distribution of menthol cigarettes

On July 24, 2013, the U.S. Food and Drug Administration issued an advance notice of proposed rulemaking (ANPRM) seeking comments from the public and other stakeholders on the potential regulation of menthol in cigarettes.   Gottlieb and Daynard from PHAI submitted comments today on Docket No. FDA-2013-N-0521 calling on the Secretary of Health and Human Services to

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Lorillard Inc., v. United States Food and Drug Administration, No. 11-440

On February 21, 2011, Lorillard Tobacco Company and R.J. Reynolds Tobacco Company filed a complaint[1] against the FDA in the United States District Court for the District of Columbia challenging the composition of the Tobacco Products Scientific Advisory Committee (“TPSAC”) and alleging that TPSAC failed to comply with the Federal Advisory Committee Act (“FACA”). TPSAC

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R.J. Reynolds Tobacco Co. v. Food & Drug Admin., NO. 11-5332

In August, 2011, five tobacco companies[1] filed a complaint[2] against the FDA in the United States District Court for the District of Columbia alleging that certain provisions of the Family Smoking Prevention and Tobacco Control Act (“Tobacco Act”) violated their First Amendment right to free speech.[3] The tobacco companies challenged the graphic warning requirements which

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Disc. Tobacco City & Lottery, Inc. v. United States

In August, 2009,  tobacco manufacturers and sellers[1]  brought suit[2] in the United States District Court for the Western District of Kentucky against the FDA, challenging provisions of the Family Smoking Prevention and Tobacco Control Act (“Tobacco Act”). In a case previously known as Commonwealth Brands, Inc v. United States, plaintiffs challenged the following requirements as

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